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New surgical fixation system aims to improve bone healing after foot and ankle reconstruction

NCT ID NCT04812353

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study follows 208 adults who are scheduled for foot or ankle reconstruction surgery using the Io-Fix system, a device designed to stabilize bones during healing. The goal is to measure how well the bones fuse and how patients recover, using X-rays and health questionnaires. Researchers hope to confirm whether the Io-Fix system improves healing and identify any unexpected problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Io-Fix system (a surgical fixation device)
What this could lead to
If the Io-Fix system proves effective, it could lead to faster and more reliable bone healing after foot or ankle reconstruction surgery.
What could go wrong
This is an observational follow-up study, not a controlled trial, so results may not prove the system is better than other methods. Some patients may still experience delayed healing or complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

208 people

The number who actually took part.

Started

Apr 2014

Finished

Sep 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure 1. Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction 2. Tibio-talar arthrodesis or prosthesis 3. Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis 4. Pantalar arthrodesis with or without inclusion of the Chopart joint Exclusion Criteria: * Age under 18

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Conditions

The condition(s) this trial relates to.

ankylosis flatfoot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Foot and ankle arthrodesis Foot and ankle osteotomy

Contacts and locations

Locations

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

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